Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device – A Randomized Clinical Trial in Acute Kidney Injury

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Description

This randomized, controlled, pivotal study is intended to determine whether up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) will improve survival in patients with Acute Kidney Injury (AKI) requiring continuous kidney replacement therapy (CKRT) when compared to CKRT alone (standard of care). This study is further intended to determine whether SCD therapy will reduce the duration of maintenance dialysis secondary to AKI. This study will enroll approximately 200 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT.

Targeted Conditions

Study Overview

Start Date
April 17, 2023
Completion Date
November 1, 2025
Enrollment
200
Date Posted
March 7, 2023
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
JMS Burn Center
Augusta, Georgia 30909, United States

University of Michigan
Ann Arbor, Michigan 48109, United States

Henry Ford Medical Center
Detroit, Michigan 48202, United States

Samaritan Health
Corvallis, Oregon 97330, United States

Methodist Hospital
San Antonio, Texas 78229, United States

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Admitted to an ICU requiring CKRT:

Must have AKI stage 2 or greater at the time of CKRT initiation.
Must have been on CKRT for at least 12 hours but no greater than 48 hours at the time of enrollment.
At least 18 years of age but not older than 80 at the time of enrollment.
One additional life-threatening organ dysfunction present.
Acceptable vascular access for CKRT to include adequate lumen size and length of catheters.
Initial (non-binding) commitment to maintaining current level of care for at least 96 hours.
C-Reactive Protein >3.5 mg/dl.

Exclusion Criteria:

Not expected to survive next 24 hours.
Anticipated transition to comfort measures or hospice in next 4 days.
Terminal condition whereby the patient is not expected to survive 28 days or any condition in which therapy is regarded as futile by the PI.
Advanced malignancy which is actively being treated or may be treated with palliative chemotherapy or radiation.
ICU hospitalization > 14 days during this hospital admission (to include days spent at ICU of an outside hospital) at the time of screening.
Active COVID-19 infection with a primary admission diagnosis of COVID-19.
Acute or chronic use of ventricular assist devices.
ESRD requiring chronic kidney replacement therapy.
History of CKD (greater than Stage 3).
AKI stage 0 or stage 1 at the time of CKRT initiation.
Non-ATN AKI diagnosis. We intend on relying on local nephrology subspecialty expertise to reasonably exclude non-ATN diagnoses based on clinical suspicions combined with prespecified objective criteria. If there is a reasonable suspicion that the subject has non-ATN AKI based on this, they will be excluded from the trial.
Acute coronary syndromes, acute stroke, or acute major vascular compromise requiring medical or surgical interventions within 48 hours of randomization.
Active hemorrhage requiring blood transfusions at the time of screening.
Acute on Chronic Liver Failure.
Suspicion of hepato-renal syndrome.
Presence of any solid organ transplant at any time prior to admission.
Severe burns >45% total body surface area.
Bone marrow transplant within the last year.
Chronic immunosuppression.
Individuals who have a history of primary or secondary immune disorders including, but not limited to, HIV or AIDS.
Dry weight of >150kg.
Platelet count <15,000/mm3.
Patient is a prisoner or member of a vulnerable population.
Patient is pregnant or breast feeding.
Concurrent enrollment in another interventional clinical trial for an investigational drug or device.
Requiring plasmapheresis for any reason during the hospitalization.

Study Contact Info

Study Contact Name
Mohamed Zidan, MD; Kevin K Chung, MD
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
Yes
NCTid (if applicable)
NCT05758077